Identification of Graphic Markers of Neurocognitive Disorders (MG)

NCT ID: NCT05537688

Last Updated: 2024-02-23

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 53 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-06-27
• Study Completion Date: 2023-08-27

Brief Summary

The diagnosis of neurocognitive disorders such as early Alzheimer's disease (AD) or primary progressive aphasia (PPA) is particularly difficult and constantly evolving, often leading to diagnostic erraticity. However, several studies have shown that graphic parameters are affected in people with moderate to severe Alzheimer's disease. The use of new technologies in the study and analysis of the abilities of people with neurodegenerative diseases is increasingly recommended. The use of a digital tablet with a stylus makes it possible to objectivize the kinematic parameters of writing (pressure, inclination, speed, jerk, time of writing task) and thus would allow a low-cost diffusion of this technology in particular by including it in already existing screening batteries.

The overall objective of the project is to characterize and compare the graphical markers of a writing task, either language-based (writing words, non-words, sentences) or non-language-based (drawing shapes), in patients with PPA, early-stage Alzheimer's disease (i.e., at the stage of minor neurocognitive disorders and major neurocognitive disorders at the beginning of the disease), and in people with no cognitive disorders.

Conditions

Alzheimer Disease; Primary Progressive Aphasia; Neurocognitive Disorders

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Control group

Participants will complete a graphic task included in a validated test for language impairment in adults and the elderly (DTLA).

They must not have a diagnosis of minor or major neurocognitive disorder.

Identification of Graphic Markers

Intervention Type: BEHAVIORAL

The study consists of a single physical visit to the research team's site.

Participants will take a graphic task included in a validated test for language impairment in adults and older adults (DTLA). This test with writing data has a maximum completion time of 15 minutes. Diagnostic data will be collected from the patient's chart, frailty data and socio-demographic data will be collected by self-questionnaires.

Participants will be evaluated by the principal investigator or his or her representatives from the research team.

Alzheimer's Disease group

Participants will complete a graphic task included in a validated test for language impairment in adults and the elderly (DTLA).

They must have mild stage Alzheimer's disease: 1/ Be diagnosed according to ICD-10 criteria for the following conditions: Alzheimer's disease and 2/ Have an MMSE score between 20 and 27, corresponding to a major TNC of mild stage or have a diagnosis of minor TNC with an MMSE score between 25 and 30, the validity period of a previously done MMSE is 3 months.

Identification of Graphic Markers

Intervention Type: BEHAVIORAL

The study consists of a single physical visit to the research team's site.

Participants will take a graphic task included in a validated test for language impairment in adults and older adults (DTLA). This test with writing data has a maximum completion time of 15 minutes. Diagnostic data will be collected from the patient's chart, frailty data and socio-demographic data will be collected by self-questionnaires.

Participants will be evaluated by the principal investigator or his or her representatives from the research team.

PPA group

Participants will complete a graphic task included in a validated test for language impairment in adults and the elderly (DTLA).

They must have Primary Progressive Aphasia according to the Gorno-Tempini criteria (Gorno-Tempini et al., 2011) and have an MMSE score between 20 and 27, corresponding to mild stage major CND or have a diagnosis of minor CND with an MMSE score between 25 and 30, the validity period of a previously made MMSE is 3 months.

Identification of Graphic Markers

Intervention Type: BEHAVIORAL

The study consists of a single physical visit to the research team's site.

Participants will take a graphic task included in a validated test for language impairment in adults and older adults (DTLA). This test with writing data has a maximum completion time of 15 minutes. Diagnostic data will be collected from the patient's chart, frailty data and socio-demographic data will be collected by self-questionnaires.

Participants will be evaluated by the principal investigator or his or her representatives from the research team.

Interventions

Identification of Graphic Markers

The study consists of a single physical visit to the research team's site.

Participants will take a graphic task included in a validated test for language impairment in adults and older adults (DTLA). This test with writing data has a maximum completion time of 15 minutes. Diagnostic data will be collected from the patient's chart, frailty data and socio-demographic data will be collected by self-questionnaires.

Participants will be evaluated by the principal investigator or his or her representatives from the research team.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• = > 50 years old

For control group :

• not have a diagnosis of minor or major neurocognitive disorder.

For AD :

• Have mild stage Alzheimer's disease: 1/ Be diagnosed according to ICD-10 criteria for the following conditions: Alzheimer's disease and 2/ Have an MMSE score between 20 and 27, corresponding to a major TNC of mild stage or have a diagnosis of minor TNC with an MMSE score between 25 and 30, the validity period of a previously done MMSE is 3 months.

For PPA :

• Have Primary Progressive Aphasia according to the Gorno-Tempini criteria (Gorno-Tempini et al., 2011) and have an MMSE score between 20 and 27, corresponding to major mild TNC or have a diagnosis of minor TNC with an MMSE score between 25 and 30, the validity period of a previously made MMSE is 3 months.

Exclusion Criteria

• Presence of pathologies of the dominant upper limb(s) (left, right or ambidextrous lateralization) disabling such as osteoarthritis, finger amputation, etc.
• History of stroke.
• Illiterate person.
• Participate in a concurrent experimental clinical study, to avoid interference with our study.
• Not understand oral and written French. The speakers are French-speaking and the language task is performed in French.

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Centre integre universitaire de sante et de services sociaux du Centre-Sud-de-l'Île-de-Montréal

OTHER_GOV

Sponsor Role: lead

Responsible Party

Olivier Beauchet

MD, PhD, Senior researcher, Director of laboratory

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

CRIUGM

Montreal, Quebec, Canada

Countries

Canada

Other Identifiers

2023-1632

Identifier Type: -

Identifier Source: org_study_id